Abstract

BackgroundFoot orthoses are routinely used to treat plantar fasciopathy in clinical practice. However, minimal evidence exists as to the effect of both truly custom designed foot orthoses, as well as that of the shoe the foot orthoses are placed into. This study investigated the effect of wearing custom foot orthoses and new athletic footwear on first-step pain, average 24-h pain and plantar fascia thickness in people with unilateral plantar fasciopathy over 12 weeks.MethodsA parallel, three-arm randomised controlled trial with blinding of participants and assessors. 60 participants diagnosed with unilateral plantar fasciopathy were randomised to either custom foot orthoses and new shoes (orthoses group), a sham insole with a new shoes (shoe group) or a sham insole placed in the participant’s regular shoes (control group). Primary outcome was first-step pain. Secondary outcomes were average 24-h pain and plantar fascia thickness measured on ultrasound. Outcomes were assessed at baseline, 4 week and 12 week trial time-points.ResultsAt 4 weeks, the orthoses group reported less first-step pain (p = 0.002) compared to the control group. At 12 weeks, the orthoses group reported less first-step pain compared to both the shoe (p = < 0.001) and sham (p = 0.01) groups. Both the orthoses (p = < 0.001) and shoe (p = 0.006) groups reported less average 24-h pain compared to the control group at 4 and 12 weeks. The orthoses group demonstrated reduced plantar fascia thickness on ultrasound compared to both the shoe (p = 0.032) and control groups (p = 0.011).ConclusionsCustom foot orthoses in new shoes improve first-step pain and reduce plantar fascia thickness over a period of 12 weeks compared to new shoes alone or a sham intervention.Trial registrationAustralian New Zealand Clinical Trials Registry (ACTRN 12613000446763). Submitted on the 10th of April 2013 and registered on the 18th of April 2013.

Highlights

  • Foot orthoses are routinely used to treat plantar fasciopathy in clinical practice

  • Whittaker et al concluded that the use of foot orthoses in individuals with plantar heel pain is beneficial in the medium term (7 to 12 weeks) 12 weeks regardless of whether prefabricated, accommodative or custom orthoses are used [15]

  • Based on previous results of foot orthoses, we hypothesised that the orthoses group would report less pain at 12 weeks compared to a sham group

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Summary

Introduction

Foot orthoses are routinely used to treat plantar fasciopathy in clinical practice. minimal evidence exists as to the effect of both truly custom designed foot orthoses, as well as that of the shoe the foot orthoses are placed into. The later conclusion was based on small, yet non-significant effects favouring foot orthoses On face value, these contradictory results present a high-degree of confusion and uncertainty for clinicians as to the effect of foot orthoses, and how to appropriately use them, in the treatment of plantar heel pain. A recent editorial has identified that the difference in the conclusions between the two reviews is a result of the different pain outcome extracted by the respective authors from one of the studies included in the reviews [17] This suggests that current pooled evidence demonstrates a small effect favouring foot orthoses, with the need for further high-quality randomised controlled trials to interpret whether such an effect is important in the context of clinical management

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